SOFT MATE(R) DW (HEFILICON A) CONTACT LENS

FDA Premarket Approval N17367 S012

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

DeviceSOFT MATE(R) DW (HEFILICON A) CONTACT LENS
Generic NameSterilizer, Soft-lens, Thermal, Ac-powered
ApplicantWESLEY JESSEN CORP.
Date Received1983-12-20
Decision Date1984-04-16
PMAN17367
SupplementS012
Product CodeHRD 
Advisory CommitteeOphthalmic
Expedited ReviewNo
Combination Product No
Applicant Address WESLEY JESSEN CORP. 333 E. Howard Ave. des Plaines, IL 60018-5903

Supplemental Filings

Supplement NumberDateSupplement Type
N17367Original Filing
S013 1985-03-04
S012 1983-12-20
S011 1983-11-14
S010
S009 1980-02-05
S008
S007
S006
S005 1974-10-01
S004
S003
S002
S001 1979-02-06

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